Bayer Reports Positive Phase III Results for Investigational Cardiac Amyloidosis Imaging Agent

Bayer announced positive topline results from the Phase III REVEAL study evaluating I 124 evuzamitide, an investigational PET/CT imaging agent designed to diagnose cardiac amyloidosis.

The study met its primary endpoints for both sensitivity and specificity based on visual PET scan interpretation, marking a potentially significant advance in the diagnosis of a disease that is frequently underdiagnosed or misdiagnosed.

The company plans to present full study findings at an upcoming scientific conference and discuss potential regulatory submissions with the US Food and Drug Administration and other health authorities.

What Is Cardiac Amyloidosis?

Cardiac amyloidosis is a progressive and often life-threatening condition caused by the buildup of abnormal amyloid proteins in heart tissue. As these proteins accumulate, the heart becomes:

• Thickened
• Stiffened
• Less effective at pumping blood

The disease can eventually lead to:

• Heart failure
• Frequent hospitalizations
• Reduced quality of life
• Early mortality

Current estimates suggest cardiac amyloidosis affects approximately 400,000 patients worldwide, although experts believe the actual number may be significantly higher due to underdiagnosis.

Why Diagnosis Remains Difficult?

One of the biggest challenges in cardiac amyloidosis is delayed diagnosis. Patients often undergo:

• Multiple specialist consultations
• Several imaging procedures
• Lengthy diagnostic journeys

before receiving an accurate diagnosis. Currently, there is no single non-invasive test capable of reliably:

• Detecting cardiac amyloidosis
• Differentiating disease subtypes
• Quantifying amyloid burden
• Monitoring disease progression over time

REVEAL Study Demonstrates Strong Diagnostic Performance

The REVEAL Phase III study evaluated the investigational PET radiotracer I 124 evuzamitide in patients with suspected cardiac amyloidosis. The multicenter trial included:

• 170 adult participants
• 19 study centers across the United States
• Open-label, single-arm design

Participants received:

• A single intravenous dose of I 124 evuzamitide
• PET/CT imaging performed 3–5 hours later

Independent cardiac PET physicians interpreted imaging results while blinded to patient clinical data. The study used standard-of-care clinical diagnosis as the reference standard. According to Bayer, the trial successfully met primary endpoints for:

• Diagnostic sensitivity
• Diagnostic specificity

Secondary analyses also evaluated diagnostic performance in:

• Light-chain amyloidosis (AL)
• Transthyretin amyloidosis (ATTR)

Potential Benefits of a Single PET Imaging Test

According to Sharmila Dorbala, the findings suggest the imaging agent could potentially help clinicians:

• Identify cardiac amyloidosis earlier
• Exclude the disease more confidently
• Distinguish cardiac amyloidosis from other causes of heart failure
• Differentiate amyloid subtypes when combined with laboratory testing
• Monitor changes in cardiac amyloid burden over time

A sensitive and quantitative PET imaging approach could significantly improve diagnostic accuracy and patient management.

Bayer Expands Precision Imaging Strategy

I 124 evuzamitide was acquired by Bayer from Attralus Inc. earlier in 2026. The acquisition expanded Bayer’s precision imaging pipeline with amyloid-targeting radiotracers focused on systemic amyloid diseases. The compound has already received:

• Breakthrough Therapy Designation in the US
• Orphan Drug Designation in both the US and EU for:
  • Light-chain amyloidosis (AL)
  • Transthyretin amyloidosis (ATTR)

However, the imaging agent remains investigational and has not yet been approved in any country.

Molecular Imaging Gains Momentum

The study also highlights growing industry interest in molecular imaging technologies. Molecular imaging allows physicians to visualize biological processes at the cellular and molecular level in real time, supporting:

• Earlier disease detection
• More precise diagnosis
• Personalized treatment planning
• Disease monitoring

Bayer continues to invest heavily in radiology and molecular imaging technologies as part of its broader healthcare strategy. In 2025, Bayer’s radiology business generated approximately €2.2 billion in sales across imaging modalities including:

• PET
• CT
• MRI
• X-ray

Why These Results Matter?

Cardiac amyloidosis is increasingly recognized as an important and underdiagnosed cause of heart failure, particularly among older adults. As awareness grows, the need for accurate, non-invasive diagnostic tools is becoming more urgent.

The positive REVEAL study results suggest I 124 evuzamitide could potentially become an important advancement in cardiac amyloidosis diagnosis, helping physicians identify patients earlier and guide more targeted treatment decisions.

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